BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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18 BioPharm International eBook September 2019 Regulatory Sourcebook Pharmacopoeia Compliance Series J. MARK WIGGINS is owner and compendial consultant with Global Pharmacopoeia Solutions LLC. JOSEPH A. ALBANESE is the director of Analytical Strategy and Compliance at Janssen Research and Development, LLC. C ompliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable. This fundamental principle of pharmacopoeia compliance is an important consideration for the bio/pharmaceu- tical industry, including innovator, generic, virtual, and start-up companies who discover, develop, manu- facture, and distribute small-molecule drug products, biotherapeutic products, and vaccines, as well as the drug substances and excipients used in these prod- ucts. Across the entire industry and within any given company, it is crucial that there is awareness and understanding of this need for pharmacopoeia compli- ance—from the CEOs of multi-national innovator and generic-drug companies to the leadership at small start- ups and contract manufacturers, to managers in their respective functional areas, to the analytical bench chemists and microbiologists testing active ingredi- ents and excipients for use in drug products—so that global patients have uninterrupted access to the criti- cal medicines that extend and improve their lives. J. MARK WIGGINS AND JOSEPH A. ALBANESE This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle. Why Pharmacopoeia Compliance Is Necessary iQoncept-

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